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Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment
This is an open-label, prospective, single-center, split-face Feasibility study to Evaluate 1) the safety and efficacy of the Cutera excel V™ laser and the Micro-Lens Array attachment to the Genesis V hand piece, and 2) the safety and efficacy of the Cutera excel V™ laser Green Genesis V hand piece to the CoolView hand piece.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excel V™ Laser With Green Genesis | Other | Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment for skin quality in desired area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excel V™ Laser With Green Genesis | Device | Subject(s) will receive treatments with a Cutera Excel V™ Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale | The improvement after treatment on the Global Aesthetic Improvement Scale (GAIS). Higher scores mean better outcomes 4=Very Significant Improvement 3=Significant Improvement 2=Moderate Improvement 1=Mild Improvement 0=No Change | 12 weeks post-final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ronan, MD | Cutera Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Excel V™ Laser With Green Genesis | Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Excel V™ Laser With Green Genesis | Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Aesthetic Improvement Scale | The improvement after treatment on the Global Aesthetic Improvement Scale (GAIS). Higher scores mean better outcomes 4=Very Significant Improvement 3=Significant Improvement 2=Moderate Improvement 1=Mild Improvement 0=No Change | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-final treatment |
|
|
Up to 12 weeks post-final treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Excel V™ Laser With Green Genesis | Treatment with Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-656-9612 | mdoucette@cutera.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2017 | Jul 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |